Non Carbonic Buffer Power of Critical Ill Patients With Sepsis

Sponsor
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico (Other)
Overall Status
Completed
CT.gov ID
NCT03503214
Collaborator
(none)
36
1
11.5
3.1

Study Details

Study Description

Brief Summary

Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.

The human organism is protected against acid-base disorders by several compensatory mechanisms that minimize pH variations in case of blood variations in carbon dioxide content. The aim of the present study is to quantify the buffer power, i.e. the capacity to limit pH variations in response to carbon dioxide changes, in critically ill septic patients and compare these results with data collected from healthy volunteers.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: In vitro determination of non-carbonic buffer power
  • Diagnostic Test: Classic description of acid-base status

Detailed Description

Alterations of acid-base equilibrium are very common in critically ill patients and understanding their pathophysiology can be important to improve clinical treatment.

The human body is protected against acid-base disorders by several compensatory mechanisms that minimize pH variations in response to acid-base derangements.

The present study focuses on the acute compensatory mechanisms of respiratory acid-base derangements, i.e., respiratory acidosis and respiratory alkalosis. In this case the non-carbonic buffers are constituted by albumin and phosphates in plasma, with the addition of hemoglobin in whole blood.

Aim of the present in-vitro study is to measure the buffer power of non-carbonic weak acids contained in whole blood and isolated plasma, assess the relative contribution of red blood cells and plasma proteins and perform a comparison between septic patients and healthy controls.

Study Design

Study Type:
Observational
Actual Enrollment :
36 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Changes in Acid-base Variables Induced by Acute Variations in Partial Pressure of Carbon Dioxide in Whole Blood and Isolated Plasma of Septic Critically Ill Patients and Healthy Volunteers: an In-vitro Study
Actual Study Start Date :
Mar 7, 2018
Actual Primary Completion Date :
Feb 20, 2019
Actual Study Completion Date :
Feb 20, 2019

Arms and Interventions

Arm Intervention/Treatment
Septic patients

Patients with sepsis or septic shock according to the SEPSIS-III (Singer M Jama 2016) admitted to the general Intensive Care Unit

Diagnostic Test: In vitro determination of non-carbonic buffer power
In vitro measurement of the non-carbonic buffer power by the means of equilibration of whole blood and isolated plasma with gas mixtures containing different concentrations of carbon dioxide

Diagnostic Test: Classic description of acid-base status
Measurement of plasma electrolytes, hemoglobin concentration, albumin and phosphates to compute acid-base variables according to Stewart's approach.

Healthy volunteers

Subjects without known respiratory, cardiovascular, hepatic, renal or hematologic diseases.

Diagnostic Test: In vitro determination of non-carbonic buffer power
In vitro measurement of the non-carbonic buffer power by the means of equilibration of whole blood and isolated plasma with gas mixtures containing different concentrations of carbon dioxide

Diagnostic Test: Classic description of acid-base status
Measurement of plasma electrolytes, hemoglobin concentration, albumin and phosphates to compute acid-base variables according to Stewart's approach.

Outcome Measures

Primary Outcome Measures

  1. Non-carbonic buffer power [1 day]

    Non-carbonic buffer power (beta) of whole blood and isolated plasma [expressed as variations in bicarbonate concentration divided by variations in pH).

Secondary Outcome Measures

  1. Strong Ion Difference variations induced by carbon dioxide [1 day]

    Variations in Strong Ion Difference of whole blood and plasma [expressed in milliequivalents per Liter], induced by acute in vitro changes of carbon dioxide

  2. Bicarbonate Variations induced by carbon dioxide [1 day]

    Variations in bicarbonate concentration of whole blood and plasma [expressed in milliequivalents per Liter], induced by acute in vitro changes of carbon dioxide

  3. Oxidized albumin [1 day]

    Oxidized albumin [expressed as percentage of total albumin concentration]

  4. Correlation between hematocrit values and Strong Ion Difference variations [1 day]

    Correlation between hematocrit [expressed as percentage] values and Strong Ion Difference variations [expressed in mEq/L] induced by acute in vitro changes of Carbon Dioxide. Acute variations in partial pressure of carbon dioxide cause changes in Strong Ion Difference. The hypothesis is that the magnitude of Strong Ion Difference variations correlate to the hematocrit, being the red blood cell the major source of electrolytes. The higher the hematocrit, the higher the possible change in Strong Ion Difference induced by acute variations in partial pressure of carbon dioxide.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Septic patients and healthy volunteers
Exclusion Criteria:
  • age < 18 years and pregnancy

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milan Italy 20122

Sponsors and Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Thomas Langer, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
  • Study Director: Antonio Pesenti, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano
  • Study Chair: Giacomo Grasselli, MD, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico di Milano

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
ClinicalTrials.gov Identifier:
NCT03503214
Other Study ID Numbers:
  • Buffer power
First Posted:
Apr 19, 2018
Last Update Posted:
Apr 25, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 25, 2019